The QC Microbiologist II will have several responsibilities in the QC group. The analyst will perform environmental monitoring (EM) for particulates and viable samples in support of cGMP manufacturing which includes several production suites of ISO class 5, 7, and 8 as well as EU Grade A to D in a GMP facility that produces biopharmaceuticals (vaccines, biologics, viral vaccines, monoclonal antibodies, etc.). In addition, monitoring of purified water, and compressed gases systems is required. Additional responsibilities may include EM data review and compilation of data, report writing, and trending of data; investigations, gowning training and annual gowning qualification.

Responsibilities:

Perform environmental monitoring for HVAC (viable air, viable surface, total particulates), personnel monitoring, purified water (conductivity, TOC, bioburden). Perform entry of data as needed into EM database. Assist in generation of quarterly and annual trend reports. Participate in visual inspection program of final products as part of fill-finish activities. Perform sample log-in, assignment of accession numbers and coordinate shipment of samples to outside test labs.

Perform microbiological testing such as:

bioburden, endotoxin, growth promotion, etc. Assist quality record completion (OOS, EM investigations, deviations, change control, CAPAs). Support product labeling and packaging activities. Assist raw material release activities. Perform QC Laboratory testing accurately and to schedule as per written procedures. Record all data, observations and QC results accurately with attention to detail. Order and maintain laboratory reagents and supplies. Vaccination in support of upcoming projects. Other duties as assigned.

Qualifications and Education Requirements:

Bachelor's degree in microbiology, biology or related scientific field A minimum of 3 years related experience with biological products, in a GMP Quality Control laboratory. Experience performing EM, purified water sampling and testing Experience with bioburden, endotoxin, TOC and conductivity a plus. Requires excellent written and verbal communication skills. Computer (PC) and software skills including MS Office Suite Excel and Word programs. Must have experience with cGMP and quality systems including OOS and EM investigations, deviations, change control and CAPAs. High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines. Demonstrated ability to work independently as well as be a strong team contributor Strong communication Takes initiative Works well with all types of people Remains calm under pressure

OTHER REQUIREMENTS

Must comply with all immunizations required by the company, regulatory agencies, applicable law, and Occupational Health protocols as a condition of employment, as this position requires access to laboratory, laboratory support areas, and handling of biological materials.

Job Type:

Full-time Pay:

From $70,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible schedule Flexible spending account Health insurance Life insurance Paid time off Parental leave Referral program Retirement plan Tuition reimbursement Vision insurance

Work Location:

In person